FDA's "lethal weaknesses"

The events described below, which have led The Lancet to write of "lethal weaknesses in the U.S. Food and Drug Administration's regulatory oversight", should not come as a surprise. They are yet another clear illustration as to whose side the FDA is on.

Those scientists within the FDA who are known to have raised safety concerns about GMOs never stood a chance. The FDA's own records reveal it declared GM foods to be safe in the face of broad disagreement from its own experts while the FDA claimed scientific consensus. The FDA has even acknowledged it has been operating under a government policy "to foster" the U.S. biotechnology industry.
http://www.bio-integrity.org/FDADeception.html

The articles below about drug regulation in the U.S., and in particular the gagging and denigration of the FDA's senior drug safety officer, Dr David Graham, are not describing an isolated instance even in the drug safety sector.

What's happening to Graham was almost exactly paralleled with GlaxoSmithKline's Paxil and selective serotonin reuptake inhibitors (SSRIs). In that case, the FDA refused to let Dr. Andrew Mosholder, of the FDA Office of Drug Safety, present to an advisory panel the findings of an analysis of clinical trials related to antidepressant use in children. That analysis had found a heightened risk of suicidality (suicidal tendencies). Indeed, according to an investigation by Sen. Charles Grassley (see item 2) the FDA actually tried to get Mosholder to present data that deceptively underrepresented the risk of suicidality.
http://www.alternet.org/story/21088/

What has emerged about the FDA gives added significance to the notorious comment made by Phil Angell, when Monsanto's director of corporate communications:

"Monsanto should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its safety is the FDA's job." - New York Times, October 25, 1998

As Dr. Herbert Ley, Former FDA Commissioner, once put it, "What the FDA is doing and what the
public thinks it's doing are as different as night and day."

1.Merck: 55,000 Dead
2.FDA scientist censored
3.Regulators Are Trying to Quash Study, Senator Says
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1.Merck: 55,000 Dead
10 WORST CORPORATIONS OF 2004
http://www.alternet.org/story/21088/

It's not as if people in power didn't know about the impending disaster – what David Graham, a Food and Drug Administration (FDA) drug safety official, calls "maybe the single greatest drug-safety catastrophe in the history of this country."

Testifying before a Senate committee in November, Dr. Graham put the number in the United States who had suffered heart attacks or stroke as result of taking the arthritis drug Vioxx in the range of 88,000 to 139,000. As many as 40 percent of these people, or about 35,000-55,000, died as a result, Graham said.

The unacceptable cardiovascular risks of Vioxx were evident as early as 2000 – a full four years before the drug was finally withdrawn from the market by its manufacturer, Merck, according to a study released by the Lancet, the British medical journal.

"This discovery points to astonishing failures in Merck's internal systems of post-marketing surveillance, as well as to lethal weaknesses in the U.S. Food and Drug Administration's regulatory oversight," Lancet editors wrote.

...Dr. Graham, the federal drug-safety reviewer, continues to seek to publish his study demonstrating the dangers of Vioxx, but he has been delayed and demeaned by top officials at the Food and Drug Administration.

At the Senate hearing, Dr. Graham said that the FDA "as currently configured is incapable of protecting America against another Vioxx," because of ties between agency reviewers and the pharmaceutical industry. Graham says that as a result of his testimony, his bosses have threatened to toss him out of the FDA's drug safety unit.

At the Senate hearing, Graham said that at least five medications currently on the market pose such risks that their sale ought to be limited or stopped.

In November 2004, Forbes.com named David Graham "face of the year." We join with Forbes in saluting Graham "for his steadfast advocacy of drug safety
and his willingness to blow the whistle on his bosses."
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2.Cox-2s safety summit sees FDA scientist censored
By Katherine Griffiths in New York and Stephen Foley in London
The Independent, 16 February 2005
http://news.independent.co.uk/business/news/story.jsp?story=611452

David Graham, the high-profile scientist at America's Food and Drug Administration, has been banned from presenting new information about a controversial type of painkiller at a three-day summit on their safety starting today.

Dr Graham, who works in the FDA's office of drug safety, said yesterday that he had been "threatened with being called insubordinate" by the FDA when he said he wanted to include the findings of an unpublished study he has completed as part of his testimony on Cox-2 inhibitors.

The FDA has organised the series of hearings, which will include evidence from drug makers and scientists, in Washington in response to mounting concerns about Cox-2s and to allegations that the agency has been too slow to deal with possible dangers associated with the drugs. Last September, the US pharmaceuticals giant Merck withdrew Vioxx after a study showed the blockbuster increased the risk of heart disease five-fold in patients on a high dose.

Relations between Dr Graham and his employer have been strained since he spoke out against the way the FDA handled Vioxx, which he said caused heart problems in up to 140,000 patients.

Last November, the FDA publicly repudiated comments by Dr Graham naming five drugs, including AstraZeneca's cholesterol lowering pill Crestor and GSK's asthma drug Serevent, that he thought could be too dangerous for use.

The agency argued that it has struck the right balance of benefits and risks when assessing new drugs for launch, but it has been accused of being too close to the drug industry and has faced political calls to split its safety monitoring functions into an agency separate from the drug approvals process.
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3.Drug Regulators Are Trying to Quash Study, Senator Says
By GARDINER HARRIS
New York Times, February 12, 2005
http://www.nytimes.com/2005/02/12/politics/12fda.html

WASHINGTON, Feb. 11 - The tension and intrigue surrounding a crucial federal drug advisory committee meeting next week, already high, reached a boil on Friday when Senator Charles E. Grassley charged that top federal drug regulators intended to suppress an important study.

The panel has been convened to discuss whether Celebrex and Bextra, heavily selling arthritis pills from Pfizer, hurt the heart and are worth their potential risks. But top officials of the Food and Drug Administration have forbidden Dr. David Graham, a drug-safety officer at the agency, to discuss before the panel a large study of that very question, said Dr. Gurkirpal Singh of Stanford University School of Medicine, Dr. Graham's co-author.

"We have significant new information that will alter the thinking about these drugs," Dr. Singh said. "I don't understand why they won't let us present this information."

Mr. Grassley, an Iowa Republican, wrote a letter Friday to the agency's acting commissioner, Dr. Lester Crawford, demanding to know by Monday the reason for the agency's decision.

Dr. Graham expressed frustration that F.D.A. officials had instructed him not to discuss the new study in a presentation he is scheduled to give to the committee on Thursday.

"This study bears directly on the whole reason why this advisory meeting is being held in the first place," Dr. Graham said.

Agency officials told him the study had not yet been properly vetted, he said.

A spokesman for the agency denied that Dr. Graham had been barred from presenting the new findings. He said that agency officials had simply expressed a preference "that he rely on published literature in his talk, but that it was his call if he wanted to offer data from his new study."

The latest charge suggests that the panel will render judgment not only on the safety of Celebrex and Bextra but also on how well the F.D.A. is doing its job.

A series of controversies have called into question whether the agency has the tools or the will to protect patients' health.

Some in Congress, including Mr. Grassley, are calling for fundamental changes at the agency. Drug-safety advocates claim that top agency officials are far too cozy with drug makers. Agency officials say they are doing a good job.

Both sides point to the story of Vioxx, a pain pill similar to Celebrex and Bextra that Merck withdrew from the market in September, an action that will also be discussed at the hearing.

"There seems to be this view that we did something wrong with Vioxx," Dr. Robert Temple, director of the agency's office of medical affairs, said in an interview. "What exactly is the thing that we did wrong? Approving it? Making them do a 6,000-patient study to get a claim? What?"

Mr. Grassley had a quick answer. "The Vioxx disaster and its aftermath have shaken the public's confidence in the Food and Drug Administration," he said, in part because, instead of listening to its best scientists, the agency is "sitting down to negotiate with drug companies."

Vera Sharav, president of the Alliance for Human Research Protection, said that the Vioxx story demonstrated that "the F.D.A. has abandoned its public responsibility to protect us from unsafe drugs and is standing by as drug companies market lethal drugs."

A Merck spokeswoman said that the company had acted appropriately in its research, marketing and eventual withdrawal of Vioxx.

Pfizer representatives say that studies show that Celebrex and Bextra are safe.

There is a sense of deja vu to Dr. Singh's latest charge. The agency convened an advisory panel a year ago to discuss whether antidepressants cause children and teenagers to become suicidal. Dr. Andrew Mosholder, another drug-safety officer for the agency, had concluded that the drugs did increase the risks of suicide. Top officials were skeptical of his findings and would not let him testify about his data before the panel.

A second study eventually confirmed Dr. Mosholder's conclusions, but the agency's refusal to let Dr. Mosholder testify caused a firestorm of criticism and prompted Mr. Grassley to begin an investigation of the agency.

The advisory panel will meet for three days beginning on Wednesday. It already has a mountain of data to sort through.

At the end of the hearings, the committee will be asked whether Celebrex and Bextra should be withdrawn or whether warnings on their labels should simply be strengthened.

The committee may debate whether the withdrawal of Vioxx was appropriate. And the committee will also discuss what, if any, studies of the drugs should be undertaken, according to F.D.A. documents.

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